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Comparative Study
. 2020 May 30:582:119266.
doi: 10.1016/j.ijpharm.2020.119266. Epub 2020 Apr 3.

Using microfluidics for scalable manufacturing of nanomedicines from bench to GMP: A case study using protein-loaded liposomes

Cameron Webb  1 , Neil Forbes  1 , Carla B Roces  1 , Giulia Anderluzzi  1 , Gustavo Lou  1 , Suraj Abraham  2 , Logan Ingalls  2 , Keara Marshall  2 , Timothy J Leaver  2 , Julie A Watts  3 , Jonathan W Aylott  3 , Yvonne Perrie  4
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Free article
Comparative Study

Using microfluidics for scalable manufacturing of nanomedicines from bench to GMP: A case study using protein-loaded liposomes

Cameron Webb et al. Int J Pharm. .
Free article

Abstract

Nanomedicines are well recognised for their ability to improve therapeutic outcomes. Yet, due to their complexity, nanomedicines are challenging and costly to produce using traditional manufacturing methods. For nanomedicines to be widely exploited, new manufacturing technologies must be adopted to reduce development costs and provide a consistent product. Within this study, we investigate microfluidic manufacture of nanomedicines. Using protein-loaded liposomes as a case study, we manufacture liposomes with tightly defined physico-chemical attributes (size, PDI, protein loading and release) from small-scale (1 mL) through to GMP volume production (200 mL/min). To achieve this, we investigate two different laminar flow microfluidic cartridge designs (based on a staggered herringbone design and a novel toroidal mixer design); for the first time we demonstrate the use of a new microfluidic cartridge design which delivers seamless scale-up production from bench-scale (12 mL/min) through GMP production requirements of over 20 L/h using the same standardised normal operating parameters. We also outline the application of tangential flow filtration for down-stream processing and high product yield. This work confirms that defined liposome products can be manufactured rapidly and reproducibly using a scale-independent production process, thereby de-risking the journey from bench to approved product.

Keywords: Continuous; Liposomes; Manufacture; Microfluidics; Nanomedicines; Scale-independent.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Suraj Abraham, Logan Ingalls and Keara Marshall are employees of Precision NanoSystems Inc. Timothy J Leaver is an employee and shareholder of Precision NanoSystems Inc..

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